Events

Alerte De Sécurité sur Cobas p 512 Pre-Analytical System, records 10287411043 and 10287410844, hazard class I, various series: 4700920; 4701020; 4701430; 4706631; 4706731; 4706831; 4706931; 4707031; 4707131; 4707231; 4707331; 4707431; 4707631; 4707831; 4708131; 4709431; 4709531; 4709631; 4709731; 4709831; 4709931; 4,710,231; 4,710,331; 4,714,441; 4,717,943; 4,719,644; 4,725,245; 4,725,345; 4,762,545; 4,727,745; 4,728,145; 4,728,245; 4,728,545; 4,730,345; 4,730,645; 4,732,745; 4,733,045; 4733245; 4,733,645; 4,733,745; 4,733,845; 4,734045; 4,735,345.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1832
  • Date
    2016-03-04
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    Actions to be taken by the client / user: It was recommended to consider that: The implementation of the software correction is mandatory for the affected systems and will be installed by a Roche Diagnostica Brasil Representative. Until the software fix is ​​implemented, it was recommended that the client / operator monitor the system for the missing tube error 140. If the described situation occurs, all components in contact with the spill must undergo an extra cleaning, as described in the operator's manual. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Cause
    Roche diagnostics gmbh, the legal manufacturer of the product involved in this notification, after a complaint reported abroad, identified the need to update and correct the software of the cobas p 512 pre-analytical system. such modification is necessary because of the incorrect insertion of (rtt), generating risk of contamination of the system and other samples, in addition to loss of material for analysis. so far, this problem has occurred in only three systems of about 400 systems installed in the world. in brazil, no similar complaint has been reported so far.
  • Action
    Action code SBN_CPS_2016_01. Send letter elaborated on 02/26/2016 of communication to affected clients //// Implementation of software correction for the equipment. If you have any questions regarding this action call 0800-7720295

Device

Cobas p 512 Pre-Analytical System, records 10287411043 and 10287410844, hazard class I, various s...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH